# K261890: 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®

- Pathway: 510(k) (Special)
- Applicant: Boehringer Laboratories, LLC
- Decided: Aug 14, 2026 after 70 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002838 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234033: ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340), Boehringer Laboratories, LLC (2024) Summary page 5.
- K234145: ViSiGi 3D Gastric Sizing Tube, Boehringer Laboratories (2024) Summary page 5.

## Indications for use
ViSiGi LUX™ is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, and to serve as a sizing guide. ViSiGi 3D® is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, and to serve as a sizing guide.

Source page: https://510kreport.com/device/K261890
Methodology: https://510kreport.com/methodology